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Blood Pressure Monitor for High Blood Pressure

N/A

Recruiting

Research Sponsored by Aktiia SA

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must be 22 to 59 years of age

Be between 18 and 65 years old

Must not have

Participants with known clotting disorders or currently taking a prescription blood thinner

Female participants who are known to be pregnant or who are trying to get pregnant confirmed by a day 1 positive urine pregnancy test unless the study participant is known to be not of child-bearing potential

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 23 hours

Awards & highlights

No Placebo-Only Group

Summary

This trial will involve 85 participants going to 8 visits spread over 23 hours to test how accurate and precise the Aktiia.product-G0 device is in measuring blood pressure and pulse rate for

Who is the study for?

This trial is for at least 85 adults with high blood pressure, representative of the US population. Participants will need to be available for 8 visits over a day and stay seated during measurements.

What is being tested?

The study tests the Aktiia Spot-check Optical Blood Pressure Monitoring Device's accuracy in measuring blood pressure and pulse rate against standard methods, over a period of up to 23 hours.

What are the potential side effects?

Since this trial involves non-invasive blood pressure monitoring, there are minimal expected side effects, primarily related to potential discomfort from wearing the device on the wrist.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 22 and 59 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a clotting disorder or am on prescription blood thinners.

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I am not pregnant nor trying to become pregnant, or I cannot become pregnant.

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I have a heart condition with irregular beats that can cause weak or unstable blood pressure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 23 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~23 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 23 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Blood pressure mean value of differences

Blood pressure standard deviation of differences

Secondary study objectives

Heart rate root-mean-square error

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Aktiia.product-G0 device under testExperimental Treatment1 Intervention

Subjects will be asked to stay seated while blood pressure and pulse rate measurements are taken at different timepoints with the device under test and references.

0 / 4Eligibility criteria met